An interventional study of Tremor Retrainer Smartphone Application in Functional Movement Disorder, Functional Neurological Disorder and Functional Neurological Symptom Disorder, sponsored by University of Virginia. Active, not recruiting at 2 sites in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by University of Virginia · Not applicable, Interventional, and Treatment
The purpose of this clinical trial is to learn about the Tremor Retrainer smartphone application and Simplified Functional Movement Disorder Rating Scale in patients with functional tremor. The main questions the study aims to answer are:
Following a one-week observation period, 20 subjects will complete the one-week four hour Tremor Retrainer smartphone protocol.
The study will consist of 4 in-person visits over 3-4 months and one televideo visit the same day as study visit 1.
For Objective 1, the investigators will evaluate mHealth Application Usability Questionnaire scores after subjects complete Tremor Retrainer protocol and compare Simplified Functional Movement Disorder Rating Scale (S-FMDRS) scores before (study visit 2) and after (study visits 3 and 4) intervention between groups.
For Objective 2, the investigators will evaluate which components can be scored after televideo administration of S-FMDRS and measure correlation between randomly-ordered sequential in-person and televideo S-FMDRS administration.
For Objective 3, the investigators will measure change and variability in S-FMDRS between study visit 1 and 2. S-FMDRS scoring will be completed via video review by a movement disorder neurologist blinded to timing of visit relative to treatment.
89 studies on the registry are indexed under Conversion Disorder; 34 are open to participants now.
This study's planned enrollment of 20 is below the median of 38 across 51 interventional studies indexed under Conversion Disorder.
Browse Conversion Disorder studies →University of Virginia is the lead sponsor of 675 studies on the registry; 138 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects will receive intervention with Tremor Retrainer smartphone application
Device: Tremor Retrainer Smartphone Application
The Tremor Retrainer smartphone application uses the smartphone's built-in accelerometer to calculate a patient's tremor frequency when the smartphone is strapped to the patient's wrist. The application will provide auditory cues to the patient with a treatment frequency at 2/3 the patient's baseline tremor frequency for half a session, then 1/3 the patient's baseline tremor frequency for the second half of the session. Meanwhile, oscillatory movements will be continuously analyzed with frequency calculated and displayed relative to goal frequency, so that the patient receives continuous feedback via a visual dial as to whether they are meeting treatment goals. Intervention will consist of a one-week Tremor Retrainment Protocol.
mHealth Application Usability Questionnaire
Usability Questionnaire. Score range: 21-147 with higher scores indicating better usability
Time frame: Study visit 3
Simplified Functional Movement Disorder Rating Scale
Videorecorded severity scale. Score range: 0-54 with higher scores indicating greater severity (worse movements)
Time frame: Study visits 1-4
Adherence
Duration of sessions completed
Time frame: Study visit 3
Clinical Global Impression Severity Scale - Clinician Rated
Clinician rated impression of tremor severity. Score range: 1-7, with 7 being most severely affected
Time frame: Study visits 1-4
Clinical Global Impression Improvement Scale - Clinician Rated
Clinician rated impression of tremor change. Score range: 1-7, with 1 being best and 7 being worst.
Time frame: Study visits 2-4
Clinical Global Impression Improvement Scale - Patient Rated
Patient rated impression of tremor change. Score range: 1-7, with 1 being best and 7 being worst.
Time frame: Study visits 2-4
Visual Analog Scale
Patient rated impression of tremor severity. Score range: 0-10, with 10 being worst tremor imaginable.
Time frame: Between study visits 2-3
36-Item Short-Form Survey
Quality of life scale. Score range: 0-100, with 100 being best.
Time frame: Study visits 1 and 4
Plan to share: Yes — Anonymized participant data, including raw scores of outcome measures will be available for review.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data anticipated to be available in 2026.
Access criteria: Anonymized participant data will be publicly available.
Data sharing details ↗ · www.ithriv.org
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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